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实质评估对我的业务有何影响?

问题(中文)
实质评估对我的业务有何影响?
Question (EN)
What is the impact of substance evaluation on my business?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
物质被列入CoRAP本身并不对注册人产生任何法律影响,因此注册人无需采取任何进一步行动。CoRAP被采纳/更新后,在CoRAP第一年列入的物质的注册人预计将在12个月的评估期后收到一份决议草案,要求其提供更多信息。届时,注册人将有机会在最终决定是否要求提供更多信息之前发表评论。最终决定将包含提交补充信息的截止日期。另一方面,如果评估成员国得出结论认为无需提供更多信息来澄清风险,则物质评估流程将结束,无需做出是否要求提供更多信息的决定。将某种物质纳入CoRAP并不一定意味着该物质对人类健康或环境构成风险,而意味着存在对其可能构成风险的担忧,需要予以澄清(确认或排除)。它也不会自动触发限制或授权等程序。但是,如果风险得到确认,负责评估物质的成员国可以在评估完成后考虑这些选项。
Answer (EN)
The listing of a substance on the CoRAP does not in itself have any legal impact on the registrant and thus does not require any further action by the registrants. When the CoRAP is adopted/updated, the registrants of substances listed for the first year of the CoRAP may expect to receive a draft decision requesting further information after the evaluation period of 12 months. At that point of time, the registrants will be given an opportunity to comment before any final decision to request further information is taken. The final decision will contain a deadline by which the additional information must be submitted. On the other hand, if the evaluating Member State comes to the conclusion that no further information is necessary to clarify the risk, the substance evaluation process is concluded without a decision to request further information. Inclusion of a substance in the CoRAP does not automatically mean that the substance poses a risk to human health or the environment, but rather that there is a concern that it may pose a risk, which needs to be clarified (confirmed or dismissed). It also does not automatically trigger, for example, the restriction or authorisation process. However, the Member State responsible for the evaluation of a substance may consider these options once the evaluation is finished, if the risk is confirmed.